The prior art is replete with attempts to design a completely satisfactory female incontinence device. One of the greatest problems involved is obtaining adequate and reliable sealing of the device to the skin of the wearer, bearing in mind the complex shape and numerous variations from person to person of the relevant part of the female anatomy.
The following patents and patent applications are exemplary of the previous designs of female incontinence devices. Williams in U.S. Pat. No. 2,483,079 describes a device 10 comprising a substantially cylindrical hollow body 16. An upwardly tapered lower surface 17 is formed on body 16 to facilitate its positioning in the vagina. An end plate 18 is secured to the other end of body 16. A discharge tube 21 is secured and protrudes from end plate 18. A suspensory belt is provided to aid in retaining device 10 in position.
Breece in U.S. Pat. No. 3,194,238 discloses a female incontinence device comprising a support means 11 which carries a tubular fitting 12. Means 11 is connected to a series of straps. Fitting 12 is adapted to be internally inserted between labia of the vulva for sealing engagement under slight pressure with surfaces surrounding the urethral orifice. The support means 11 has side walls of selected configuration for engagement with external surfaces of the labia of the vulva. The tubular member communicates through a port in the support member with a suitable drain tube which may conduct discharge to a suitable bag or receptacle.
Mayhorne in U.S. Pat. No. 3,374,790 discloses a belt supported female incontinence device. The device includes an arcuate shaped sheet 20 having a pad of flexible polymeric foam 28 surrounding an opening 26. Opening 26 leads to a funnel-like receiver 40 which in turn leads to a tube 42.
Ellis in U.S. Pat. No. 3,512,185 discloses a female urinary collection device. The device includes a forward lip normally fitting below the clitoris, U-shaped guards capable of being impressed against the introitus, a hollow body to collect urine, portions of said body capable of being enfolded by the labia minora when in position, and a runoff spout to funnel the urine to a depository.
Gross et al. in U.S. Pat. No. 3,613,122 disclose a female urination device comprising a tapering body portion connecting into an elongated discharge tube. The body portion includes a lip whereby in use urine is directed into the body portion to be discharged through the tube with the lip positioned against the body to prevent any backward dripping of urine.
Lindan in U.S. Pat. No. 3,661,155 disclosed a female incontinence device including a pessary-like support, a deformable loop extending outwardly from the support and a flexible container removably secured to an opening through the loop. The deformable loop is adapted to encircle the urethral orifice of a wearer to hold the container in a desired position when the pessary-like support is received and retained within the vagina.
Ratcliffe et al. in U.S. Pat. No. 3,776,235 disclose a female incontinence device comprising a collection and funneling container and a retaining member fixed to said container adapted for removable insertion in the vagina. The retaining member 10 is positioned in a manner such that when inserted into the vagina, the container is disposed at the urethral orifice without being in contact therewith.
Williams in U.S. Pat. No. 3,995,329 discloses a female urinary device comprising a body having an elongated lower portion with a fluid discharge passageway and an upper portion which has continuous sealing walls. Each side wall fits between a labia minora and a spread labia majora. The front wall is disposed slightly forward of the preputium clitoridis and the rear wall is disposed slightly forward of the pars intermedia. Side walls are concavely curved to generally match but somewhat distort abutted flesh.
Bermingham in U.S. Pat. No. 4,116,197 discloses a female incontinence device which consists of an adjustable belt having a flexible sheet attached thereto. A urine collection pouch depends from the sheet with a disposable vaginal pad provided between the wearer's body and the sheet.
Anderson in U.S. Pat. No. 4,194,508 discloses a female incontinence device which includes a substantially closed housing having an opening for an ingress conduit with a flexible cup-like diaphragm to fit over the urethral opening. The housing has a further opening along the length thereof to direct urine to a collection receptacle. The housing is of relatively small size as so to be substantially self supported by entrapment by at least partial covering thereof by the labial folds when positioned for use.
Cooney et al. in U.S. Pat. No. 4,198,979 disclose a female incontinent device comprising a one piece generally funnel shaped rigid collection means. There is provided a flanged lip forming a seat around the wider orifice of the collection means shaped so that the outer surface of the flanged lip when covered with a layer of adhesive can be snugly placed against the vestibule of the user and at least a portion of the inner surface of the flanged lip will be covered by the labia minora of the user to permit its normal pressure to urge the collection means against the vestibule. Preferably, a portion of the surface of the flanged lip of the collection means is warped upwardly to form a pommel which is insertable into the vagina of the user to both prevent backward movement of the device and to assist in channeling urine.
Michaud in U.S. Pat. No. 4,270,539 discloses a female urine collection device having an interface body comprising a forward portion defining a urine receiving bore having an inlet in the interface surface adapted to surround the urethral opening and a rear portion having a non-invasive vaginal seal on the interface surface for sealing the vagina of user from communicating with the urine receiving bore. An absorbent pad is removably supported on the interface body and extends laterally therefrom. Also disclosed is a garment for supporting the device.
Vincent in British Pat. No. 1,144,483 discloses a female incontinence device comprising an oval sealing ring secured to a platform which, apart from a peripheral margin is stiff so that the sides of the sealing ring which run in directions generally parallel to the major axis of the oval are prevented from closing upon one another. An outlet orifice is provided at the rear of the platform. The surface of the sealing ring remote from the zome of attachment to the platform, stands proud of the platform. A harness is provided for securing the device to the body of the patient.
Dent in British Pat. No. 1,193,261 discloses a female incontinence device comprising a receptacle consisting of a hollow body portion having a large opening at one end and a tubular opening at the opposite end. The peripheral edge of the large opening is curved to accommodate the user's body said curved periphery having a beading or rim. One end of said large opening is formed so as to extend into the vaginal passage. The appliance is supported in position on the wearer by a harness.
Disabled Living Foundation in British Pat. No. 1,422,638 discloses a female incontinence device provided with a collecting head that in plan tapers from the front end towards the rear end. The head includes a platform surrounding an opening which constitutes the mouth of the urinal and the part of the platform towards the rear boundary of the opening being sloped upwardly and inwardly to provide a hollow arched intra-labial extension which locates the head in its correct relationship to the genital anatomy of the user.
Steer in U.K. patent application No. 2,070,936A discloses a female incontinence device including an external resilient pad 18 designed to make sealing engagement with that portion of the user's anatomy that is external to the labia majora and a mount connected to or forming part of the pad. A funnel 12 is carried by the mount pad and dimensioned so that a rim thereof can engage that portion of the user's anatomy which immediately surrounds the meatus of the urethra.
Steer et al. in U.K. patent application No. 2,072,512A disclose a female incontinence device comprising a pad 10 of closed cell polyurethane having a central hole 12 therein. The pad has a funnel like device 26 covering the hole whereby urine can be conducted away.
Sokol in German Offenlegungsschrift No. 1,766,795 discloses a female incontinence device.
MacDougall in European patent application No. 56,318 discloses a female incontinence device intended for long term wear. It includes a tubular sheath 10 integral with a funnel 12 and a urine conducting pipe 14. The sheath is secured to a pad 18 of adhesive material having a central hole leading to the interior of the sheath. The pad is dimensioned so that it can be stuck to the skin of the wearer in the region immediately surrounding the urethral orifice.
In practice, it has proved very difficult to design a female incontinence device with satisfactory leak-proof sealing, especially when the device is being worn by an active person. Another problem encountered but never properly solved is that with some users there may be a sudden rapid flow of urine exiting at considerable pressure. This gives rise to splashing, and the splashed urine may cause soreness and maceration of the skin and also tends to reduce the security of attachment of the device when an adhesive is used. Yet another problem is that many previously suggested devices are undesirably rigid and therefore are both uncomfortable to wear and liable to seal inadequately against the body.